<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT2014120820239N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-01-02</date_registration>
      <primary_sponsor>University Malaya Research Grant (UMRG)</primary_sponsor>
      <public_title>Sugar control following different exercises in diabetic patients with heart disease</public_title>
      <acronym>CADEX Study</acronym>
      <scientific_title>Effects of continuous aerobic training, high intensity interval training (HIIT) and combined aerobic with resistance training on glycated haemoglobin (HbA1c) in Type 2 Diabetes Mellitus patients with coronary artery disease</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-06-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>42</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/17920</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: This is a randomized prospective trial. Randomization is done using the Peto et al method.</study_design>
      <phase>2-3</phase>
      <hc_freetext>type 2 diabetes mellitus with coronary artery disease.</hc_freetext>
      <i_freetext>Intervention 1: Continuous aerobic training: 30 minutes walking on a treadmill and 30 minutes of cycling on an upright bike with moderate intensity (50-70% VO2max). Total training duration of 60 minutes. Intervention 2: High intensity interval training (HIIT): Subjects will train on cycling ergometer which last for 10 minute duration. They will start with gradual incremental intensity training for 6 minutes (maximum intensity 60-70% VO2max) then low intensity for another 4 minutes as their warm up session. Then the HIIT session consisted of 10 minutes exercise with every 60 seconds between low intensity and high intensity alternately. The cycle ergometer is set with resistance 40% VO2max for low intensity and 60-70% VO2max for high intensity. During the 60 second high intensity session, patients are to force and encourage to increase their cycle repetition per minute to maximum with the target in achieving Borg score of 17 and above. They were monitored and supervised during the 20 minute session. Intervention 3: Combined aerobic with resistance training: Continuous 30 minutes walking on a treadmill and 30 minutes of cycling on an upright bike at moderate intensity (50-70% VO2max). Then they have to do resistance training such as chest press, latissimus dorsi pull, leg press, leg extension or leg curl, abdominal muscle crunch and back extension. Total training duration is about 90 minutes.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Moriffin Mahpis</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>5th floor Menara Selatan</address>
        <city>Petaling Jaya</city>
        <country1>Malaysia</country1>
        <zip>59100</zip>
        <telephone>006379498122</telephone>
        <email>moriffin@gmail.com</email>
        <affiliation>University Malaya Medical Centre</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Moriffin Mahpis</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>5th floor Menara Selatan</address>
        <city>Petaling Jaya</city>
        <country1>Malaysia</country1>
        <zip>59100</zip>
        <telephone>006379498122</telephone>
        <email>moriffin@gmail.com</email>
        <affiliation>University Malaya Medical Centre</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Malaysia</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients who fulfill the inclusion and exclusion criteria as listed below are recruited:&#13;
Inclusion criteria for the subjects are patients with type 2 diabetes mellitus with coronary artery disease co-morbidity manifested by one or more of these:&#13;
-Ischemic Heart Disease, but no current angina&#13;
-Post angioplasty / stenting or post coronary artery bypass surgery&#13;
-Stable pharmacological therapy&#13;
-Chronic Heart Failure New York Association (NYHA I, II and III) in the absence of congestive heart failure at the time of study&#13;
&#13;
Patients with the listed criteria are excluded from the study:&#13;
-Myocardial Infarction, Cardiac arrest, symptomatic or sustained ventricular tachycardia in the previous 6 months&#13;
-Unstable heart failure, or NYHA Class IV patients&#13;
-Symptomatic or sustained ventricular tachycardia&#13;
-Current angina or baseline assessment suggesting unsatisfactory control of heart failure&#13;
-Current acute musculoskeletal event and/or neurological impairments that adversely affect exercise capacity.&#13;
-Any other symptoms that prevent the patients from exercising.</inclusion_criteria>
      <agemin>36 years</agemin>
      <agemax>74 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E11</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>non insulin dependent diabetes mellitus</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Continuous aerobic training: 30 minutes walking on a treadmill and 30 minutes of cycling on an upright bike with moderate intensity (50-70% VO2max). Total training duration of 60 minutes.</i_keyword>
      <i_keyword>High intensity interval training (HIIT): Subjects will train on cycling ergometer which last for 10 minute duration. They will start with gradual incremental intensity training for 6 minutes (maximum intensity 60-70% VO2max) then low intensity for another 4 minutes as their warm up session. Then the HIIT session consisted of 10 minutes exercise with every 60 seconds between low intensity and high intensity alternately. The cycle ergometer is set with resistance 40% VO2max for low intensity and 60-70% VO2max for high intensity. During the 60 second high intensity session, patients are to force and encourage to increase their cycle repetition per minute to maximum with the target in achieving Borg score of 17 and above. They were monitored and supervised during the 20 minute session.</i_keyword>
      <i_keyword>Combined aerobic with resistance training: Continuous 30 minutes walking on a treadmill and 30 minutes of cycling on an upright bike at moderate intensity (50-70% VO2max). Then they have to do resistance training such as chest press, latissimus dorsi pull, leg press, leg extension or leg curl, abdominal muscle crunch and back extension. Total training duration is about 90 minutes</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>HbA1c (glycated haemoglobin). Timepoint: 12 weeks following end of treatment. Method of measurement: Blood sample laboratory test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Body composition. Timepoint: 12 weeks following end of treatment. Method of measurement: bioelectrical impedance analysis machine.</sec_outcome>
      <sec_outcome>Lipid profile. Timepoint: 12 weeks following end of treatment. Method of measurement: Blood sample laboratory test.</sec_outcome>
      <sec_outcome>Fasting blood glucose. Timepoint: 12 weeks following end of treatment. Method of measurement: Blood sample laboratory test.</sec_outcome>
      <sec_outcome>Maximum oxygen consumption (VO2max). Timepoint: 12 weeks following end of treatment. Method of measurement: cycling ergometer using Astrand or Naughton protocol.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>University Malaya Research Grant (UMRG)</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2011-10-19</approval_date>
        <contact_name>Medical Ethics Committee</contact_name>
        <contact_address>University Malaya Medical Centre Lembah Pantai Kuala Lumpur Malaysia</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
